Key Takeaways

1. Articulate the value and impact of Medical Safety (MS) and its distinction from other medical, clinical and risk management functions

2. Gain current knowledge of how and when to best incorporate MS into risk management specific to a device portfolio and right-sized to business needs,

3. Be able to apply real-world examples of successful incorporation of MS into risk management and avoid common safety pitfalls

 

Audience

This session will be tailored to audience members with varying levels of knowledge of medical device safety and risk management.

 

Session Purpose & Motivation

The development, launch, and market maintenance of medical devices is becoming ever more complex. Companies are increasingly required to employ a differentiated approach to ensure maintenance of patient safety throughout the product lifecycle. Investment in a distinct medical expertise in the form of Medical Safety professionals, which marries therapeutically relevant clinical practice experience with safety risk management, quality, R&D, regulatory, analytics and ethical principles, is a highly efficient and effective way to protect patient safety before, during, and after product launches.

This session considers key aspects incorporating such a function into risk management processes, along with practical examples, with actionable advice and insights from industry Medical Safety experts.

 

Session Description

With the introduction to distinct perspectives in MS, the audience will gain the following insights: deeper understanding of the role of MS in risk management; how and when to engage MS in risk management processes: and how MS is currently incorporated in risk management across industry (including industry best practices) including common challenging areas/pitfalls. The session will provide examples of how Medical Safety provides unique value and expertise within a MedTech company.